BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices

BS EN 62366-1:2015

Medical devices. Application of usability engineering to medical devices

Status : Current, Work in hand   Published : June 2015



What is this standard about?

Many medical devices are non-intuitive and difficult to use because they’ve been developed without attention to human factors. This is a growing cause for concern because less skilled users, including patients, are now using medical devices more often – and the devices are becoming more complicated. This standard, then, sets out to help manufacturers improve usability.  

Who is this standard for?

Manufacturers of medical equipment and systems. 

Why should you use this standard? 

It sets out a usability engineering process for medical devices that helps design straightforward and efficient user interfaces. These, in turn, will minimize user errors and reduce risks.

What’s changed since the last update?

Previously, usability engineering for medical devices was covered in BS EN 62366:2008. That document has now been fully revised into two parts:

  • Part 1, this part, contains updated normative requirements for the application of usability engineering to medical devices. 
  • Part 2, a technical report currently in preparation , will contain guidance, with a broader focus not only on safety but also on how usability relates to accuracy, completeness, efficiency and user satisfaction.   

This reduces the size of the normative standard and allows the guidance document to be updated more frequently to keep pace with the state of the art in usability engineering.

Standard NumberBS EN 62366-1:2015
TitleMedical devices. Application of usability engineering to medical devices
StatusCurrent, Work in hand
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN ISO 14971:2012, ISO 14971:2007
Informative References(Provided for Information)IEC TR 61258:2008, EN 60601-1-8:2007, EN 60601-1-6:2010/A1:2013, EN ISO 9001:2008, ISO/IEC Guide 63:2012, ISO 9000:2005, ANSI/AAMI HE 74:2001, IEC 60601-1-6:2010/A1:2013, ANSI/AAMI HE 48:1993, ISO 7010:2011, IEC 60601-1-11, EN ISO 9241-11:1998, IEC 60601-1:2005/A1:2012, EN ISO 13485:2012, IEC 60601-1:2005, GHTF SG2N31R8:2003, EN 60601-1-6:2010, ANSI/AAMI HE 75:2009, ISO 9001:2008, EN 60601-1:2006, EN 60601-1-11, ISO 9241-11:1998, EN 1041:2008, EN 1041:2008+A1:2013, EN 60601-1:2006/A1:2013, EN 60601-1-8:2007/A1:2013, IEC 60601-1-8:2006/A1:2012, EN ISO 7010:2012, ISO/TR 16142:2006, IEC 60601-1-8:2006, ISO 13485:2003, EN ISO 9000:2005, IEC 60601-1-6:2010
ReplacesBS EN 62366:2008+A1:2015
International RelationshipsEN 62366-1 Corr 1 (12/15)
Amended ByCorrigendum, January 2016
DescriptorsMedical equipment, Medical technology, Instructions for use, Medical instruments, Design, Equipment safety, Hazards, Ergonomics
Title in FrenchDispositifs médicaux. Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
Title in GermanMedizinprodukte. Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
ISBN978 0 580 91868 1
File Size2.991 MB

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